Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

N/ANot Yet RecruitingNCT06887452

VA Office of Research and Development310 enrolled

Overview

This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.

This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

310

Conditions

Gout Gouty Arthritis

Interventions

Pharmacist-LedOTHER

Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * US Veterans over the age of 18 years with physician-diagnosed * Documented hyperuricemia (SU \>6.8 mg/dL) * Satisfy ACR/EULAR gout classification criteria * Report 1 or more flares in the prior 6 months * Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria Exclusion Criteria: * Any patient intolerant or unable to take ULTs (allopurinol or febuxostat) * Patients with a rheumatology encounter within the prior 3 months

Locations (5)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

flare occurrence

The occurrence of two or more flares during year 2.

Time frame: during year two

serum urate at goal

Achievement of serum urate \<6 mg/dL at end of year one.

Time frame: at end of year one

Secondary Outcomes

Veterans RAND 12 (VR-12)

Quality of life instrument to assess components of physical and mental health. The survey asks about a patient's views on their health. The information will keep track of how a patient feels and how well they are able to do their usual activities. Scores include ranking their health from excellent to poor, whether physical or emotional health or pain limits activities or accomplishments, whether their health interferes with social activities and lastly asks patients to compare their physical and emotional health to one year ago. The scales range from not-at-all through all the time.

Time frame: Baseline visit, Months 6, 12, 18, and 24

Patient Reported Outcomes Measurement Information System (PROMIS)

Survey to assess pain on relevant aspects of a patient's life within the last 7 days. The survey asks whether or not pain interfered with enjoyment, concentration, outside-of-home tasks, and socialization. The scale is at a not at all (1) through very much (5).

Time frame: Baseline visit, Months 6, 12, 18, and 24

Gout-related patient global assessment

Participants will complete a rating scale on all the ways gout affects them on a 0-100 scale ranging from very well to very poor.

Time frame: Baseline visit, Months 6, 12, 18, and 24

Central Contacts

Bridget Kramer

CONTACT

(402) 995-3206 bridget.kramer@va.gov

Data from ClinicalTrials.gov

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